Identity
- Trade Name
- Bardex® Lubricath® Foley Catheter FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- Bardex® Lubricath® Foley Catheter 5cc Balloon Lubricious Coated FDA UDI
- Model / Reference
- 0165GL16 FDA UDI
- Description
- Bardex® Lubricath® Foley Catheter 5cc Balloon Lubricious Coated FDA UDI
Identifiers
- Catalog Number
- 0165GL16 FDA UDI
- Primary DI / UDI-DI
- 00801741046216 FDA UDI
- FDA Product Code
- EZC FDA UDI
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 16 French FDA UDI
Bardex® Lubricath® Foley Catheter by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- C. R. Bard, Inc.
Sources (1)
- FDA UDI b16bc4e7-668d-4650-9e5e-d1d3219316aa 37 fields · synced May 30, 2026